FDA Open Seminar 2017: Opportunities Ahead

February 23, 2017

Save the date for the event taking place on 1-2 June 2017 in Barcelona!

Asphalion is participating in HIVACAR H2020 project

February 17, 2017

Asphalion is one of the members of the new European project consortium aimed at obtaining a functional cure for HIV with immunotherapy

Successful eSubmissions to FDA

February 14, 2017

The FDA Electronic Submissions Gateway (ESG) enables the secure submission of regulatory information to the proper FDA Center or Office

ISO IDMP EMA official guidelines

January 25, 2017

The ISO IDMP standards establish definitions and concepts, and describe data elements and their structural relationships in order to build the unique identification of the medicinal product.

Asphalion renews its corporate image

January 23, 2017

Asphalion is excited to announce the implementation of our new corporate image.

Mandatory FDA Data Standards for Clinical and Non-clinical Studies

January 23, 2017

Study data standards will be required for most study data submitted to FDA’s

Join us in eRegulatory Summit event and get a discount!

January 23, 2017

Asphalion is proud to be the sponsor of the event and we are pleased to invite you to participate at a reduced rate

FarmaForum 2017

January 20, 2017

Asphalion is participating in the congress and our General Manager in Regulatory affairs Lidia Cánovas will run a specilized workshop.

Join us in eRA event and get a discount!

January 19, 2017

Asphalion is proud to be the sponsor of this event and we are pleased to invite you participating

Denmark phasing out NeeS

January 2, 2017

Mandatory eCTD format for national marketing authorization applications for medicinal products.

Welcome 2017!

December 23, 2016

Wishing you a happy Christmas and a prosperous new year from the Asphalion team. 

Mandatory eCTD for National Applications in Austria

December 12, 2016

From 1st January 2018, new National applications in Austria, must be submitted in eCTD format.

New managing director of Asphalion

December 1, 2016

We would like to inform you that, as and from 28 November 2016, Ms Núria Romero, partner and former Operations Manager at Asphalion is the new Managing Director of Asphalion.

Medicines for Europe 16th Regulatory and Scientific Affairs Conference in London!

December 1, 2016

Asphalion is proud to be the sponsor of the Telematics Workshop on 25th January 2017. Our Regulatory Information Director, Remco Munnik, will be the expert speaker of ISO IDMP conference.

Asphanews November 2016

November 28, 2016

Keep up on the latest news of Asphalion!

Asphalion attended Elastislet H2020 project meeting in Athens

November 24, 2016

Núria Coderch, Anna Graupera and Christopher Mann from Asphalion attended the last consortia meeting in Athens about the Horizon2020 project “Elastislet”

Biospain Press Conference

November 21, 2016

Lidia Cánovas and Marta Rayo from Asphalion presented the press conference about Asphalion participation in innovative medicines development

Effective data management for benefits beyond compliance with IDMP!

November 21, 2016

Our director of Regulatory Information, Remco Munnik, is one of the distinguished speakers in the upcoming CBI’s 2nd Annual IDMP Update Forum in Philadelphia on Dec 8-9

Fast Product’s Registration in SFDA

November 18, 2016

Saudi Arabia FDA (SFDA) is adopting a new product registration mechanism from 1st February 2017

We are proud to announce that the Spanish Government has granted us the seal of Innovative SME

November 10, 2016

Asphalion S.L. will form part of the database of Innovative SMEs in Spain until 2019.

Thanks for your visit at CPHI 2017!

October 11, 2016

We hope that this will be the beginning of a successful collaboration!

Press Conference at BioSpain2016

September 29, 2016

Asphalion brings science to the market through regulation compliance.

Places still available at the Advanced European Regulatory Affairs training starting in October in Basilea

September 28, 2016

Update on the developments in Europe for Regulatory Affairs and the impact on product development and life cycle management

More information about ISO IDMP implementation in Barcelona! Save the date!

September 1, 2016

“Jornada sobre la implementación del IDMP (Identification of Medicinal Products) y manejo de Datos” on 21st September in Barcelona.

FDA new published documents

July 28, 2016

eCTD and electronic submission will become mandatory on short future

See you at… CPHI, Biospain and TOPRA

July 25, 2016

After the holidays we have 3 important appointments, in which we can meet?

Asphanews June!

July 12, 2016

Keep up on the latest news, don’t miss it!

Do you want to know more about ISO IDMP implementation?

June 30, 2016

“Jornada sobre la implementación del IDMP (Identification of Medicinal Products) y manejo de Datos” on 5th July in Madrid

eCTD New EU Module 1 Specification

June 28, 2016

A new version of the EU eCTD Module 1 Specification (3.0.1) which can be used from 1st July 2015 and must be used from 1st October 2016.

eCTD will become mandatory for ASMF/DMF

June 22, 2016

From January 2017 EDQM will require eCTD submissions for new applications for CEPs

Upcoming new THAI eCTD and Module 1

June 21, 2016

Did you know that Food and Drug Agency of Thailand is releasing new TH Module 1 with TH regional schema V1.0. eCTD submission?